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Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

Primary Purpose

Bladder Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Interfascial Injection
Subpectineal Injection
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Neoplasm focused on measuring obturator nerve block, ultrasound guided block, bladder tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lateral wall bladder tumour
  • ASA I-II patients

Exclusion Criteria:

  • Contraindications for spinal anesthesia,
  • Tumors that disrupt the integrity of the bladder,
  • Coagulation disorders,
  • Uncooperative patients,
  • Allergy to local anesthetics.

Sites / Locations

  • Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ultrasound guided interfascial obturator nerve block

Ultrasound guided subpectineal obturator nerve block

Arm Description

In supine position, ultrasound probe will be placed on inguinal region, 2-3 cm below to the inguinal crease. Patients in this group will receive interfascial obturator nerve block under ultrasound guidance.

In supine position, the ultrasound probe will be placed on in inguinal region, 1-2 cm below to the inguinal crease to identiy the subpectineal area. Patients in this group will receive subpectineal obturator nerve block under ultrasound guidance.

Outcomes

Primary Outcome Measures

Success rate of obturatr nerve block
The success or fail of the obturator nerve block will be conformed using nerve stimulator. Detecting muscles twitch will br considered to be a fail.

Secondary Outcome Measures

Number of adductor muscle spazms
Number of adductor muscle spazms in each group will be noted during the intraoperative period.
Sensory block
Sensory block area will be evaluated by a pin prick at in the dermatomal areas related obturator nerve and branches.
Patient satisfaction
Changes in overall satisfaction will be assessed using a 5 point Likert Scale ( 1-very dissatisfied, 2- dissatisfied, 3- neutral, 4-satisfied, 5 - very satisfied
Procedure time
Block performance time will be recorded from the time the first ultrasound image is obtained until the procedure is completed

Full Information

First Posted
September 12, 2022
Last Updated
April 23, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05540847
Brief Title
Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block
Official Title
Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to assess the effectiveness of the ultrasound-guided interfascial injection approach with the subpectineal injection technique for obturator nerve block in bladder cancers undergoing transurethral resection of bladder tumor (TURBT) under spinal anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Neoplasm
Keywords
obturator nerve block, ultrasound guided block, bladder tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided interfascial obturator nerve block
Arm Type
Active Comparator
Arm Description
In supine position, ultrasound probe will be placed on inguinal region, 2-3 cm below to the inguinal crease. Patients in this group will receive interfascial obturator nerve block under ultrasound guidance.
Arm Title
Ultrasound guided subpectineal obturator nerve block
Arm Type
Experimental
Arm Description
In supine position, the ultrasound probe will be placed on in inguinal region, 1-2 cm below to the inguinal crease to identiy the subpectineal area. Patients in this group will receive subpectineal obturator nerve block under ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Interfascial Injection
Intervention Description
Interfascial Injection on Ultrasound-guided Obturator Nerve Block
Intervention Type
Procedure
Intervention Name(s)
Subpectineal Injection
Intervention Description
Subpectineal Injection on Ultrasound-guided Obturator Nerve Block
Primary Outcome Measure Information:
Title
Success rate of obturatr nerve block
Description
The success or fail of the obturator nerve block will be conformed using nerve stimulator. Detecting muscles twitch will br considered to be a fail.
Time Frame
Peroperative period
Secondary Outcome Measure Information:
Title
Number of adductor muscle spazms
Description
Number of adductor muscle spazms in each group will be noted during the intraoperative period.
Time Frame
Intraoperative period
Title
Sensory block
Description
Sensory block area will be evaluated by a pin prick at in the dermatomal areas related obturator nerve and branches.
Time Frame
30 minutes after the intervention
Title
Patient satisfaction
Description
Changes in overall satisfaction will be assessed using a 5 point Likert Scale ( 1-very dissatisfied, 2- dissatisfied, 3- neutral, 4-satisfied, 5 - very satisfied
Time Frame
Peroperative period
Title
Procedure time
Description
Block performance time will be recorded from the time the first ultrasound image is obtained until the procedure is completed
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lateral wall bladder tumour ASA I-II patients Exclusion Criteria: Contraindications for spinal anesthesia, Tumors that disrupt the integrity of the bladder, Coagulation disorders, Uncooperative patients, Allergy to local anesthetics.
Facility Information:
Facility Name
Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital
City
Yenimahalle
State/Province
Ankara
ZIP/Postal Code
06170
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

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